The present invention is in the general field of surgical instruments. More specifically, the present invention relates to repairing leaking grafts or leaks around endovascular grafts. These devices are useful for treating a patient including preventing the rupture of an aneurysm that has been fitted with a graft that has perigraft flow.
Grafts are generally tubular-shaped or Y-shaped devices that may function to bridge an aneurysm sac and thus prevent blood from flowing through the sac. Clinical studies have shown that some graft implants suffer from perigraft flow (i.e., leaks around the outside of a graft). Such perigraft flow often does not improve over time. If blood were to leak and flow through the sac, thus pressurizing the sac, then the sac might rupture and thus threaten the life of the patient. Consequently, it is useful to employ a device to stop any leaking.
Sometimes, after the flow has been directed through the inserted graft, the pressure in the aneurysm sac may remain high because of collateral flow from other vessels into and out of the sac. These collateral flows often clot and cease by themselves or with the aid of other vascular techniques. However, this clotting does not always result in a reduction in pressure in the aneurysm sac. Therefore, it would be desirable to reduce this pressure within the aneurysm sac.
When describing parts of a catheter, use of the terms proximal and distal is with respect to a user, thus the tip of the catheter is most distal and an injection port is proximal. When describing parts of the graft, use of the terms inferior and superior is with respect to the patient, superior is toward the direction of the head and inferior is toward the direction of the feet. References to thrombosis herein shall include thrombosis, hemostasis, embolization, anastomotic sealing, and void filling.
What has been needed and heretofore unavailable is a relatively simplified, safe, fast-acting, and inexpensive invention for aiding thrombosis. The present invention satisfies these needs.
Briefly, and in general terms, the present invention is directed to an apparatus and method for aiding processes including thrombosis at a treatment site of a patient. Various apparatus and methods are provided that utilize the application of electric potential in order to repair, for example, perigraft flow.
In one aspect of the invention, there is provided an apparatus for repairing a blood vessel at a treatment site of a patient. The apparatus includes an elongate hollow prosthesis for placement within a blood vessel. The prosthesis has an inner surface, an outer surface, a first end, and a second end, wherein an electric potential difference may be created between the outer surface and the inner surface.
In another aspect of the invention, there is provided a system for sealing a graft attached within a vessel at a treatment site of a patient, for preventing blood from flowing about the graft. The system includes a balloon catheter. The balloon catheter has an aperture proximate its distal end and includes an inflatable balloon at its distal end. The balloon catheter includes a balloon inflation lumen longitudinally disposed therein and an elongate tubular member lumen longitudinally disposed therein. A leaking site is accessed with a distal end of the balloon catheter by feeding the balloon catheter, via the guide wire lumen, along a guide wire that is disposed longitudinally within a graft attached within a vessel at a treatment site of a patient. The graft extends transversely across a damaged portion of the vessel and thus creates a perigraft space between the graft and the vessel wall. An elongate tubular member is provided having a conductive wire lumen therein and a sharpened distal end.
The sharpened end of the elongate tubular member is advanced through the elongate tubular member lumen such that the sharpened end of the elongate tubular member is proximate the graft. The balloon catheter is inflated via the balloon inflation port, whereby the sharpened end of the elongate tubular member is deflected into a substantially perpendicular relationship with the graft. The elongate tubular member is advanced such that the sharpened end pierces the graft and enters the perigraft space.
A conductive wire is provided. The distal end of the conductive wire is advanced through the proximal end of the elongate tubular member and out of the distal end of the elongate tubular member such that the distal end of the conductive wire enters the perigraft space.
An electric potential source is provided for connection to the conductive wire whereby the conductive wire may be positively electrically charged. A positive electric potential is applied to the conductive wire such that the conductive wire is positively electrically charged. The conductive wire thereby attracts negatively charged blood components within the perigraft space thus forming thrombosis to seal the graft. In another preferred embodiment, a sharpened wire may be used to pierce the graft, thus eliminating the need for an elongate tubular member.